Medicine
Roflumilast 250 mcg tablet
Roflumilast 250 mcg tablet is a generic prescription medicine for oral use, made by 10 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store roflumilast tablets at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Roflumilast
- Brand
- Sold under the generic name
- Strength
- 250 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 2 blister pack, 500 tablets and 25 more
- Manufacturers
- Ascend LaboratoriesIndiaMicro LabsIndiaZydus LifesciencesIndiaNovadoz PharmaceuticalsIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaJubilant Cadista PharmaceuticalsIndiaAmici PharmaAvKAREMajor Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store roflumilast tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Storage and Handling
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DX07 Roflumilast
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 September 2022
- Identifiers
- RxCUI 1091839, 2001319DailyMed set ID 93d72a99-64dc-4fde-a5b8-78331fa60787, c51b80f3-a591-4db9-81b4-b91603e35d7c, e87287bd-eae3-46c3-9072-04800aeabf40 +8NDC 67877-730, 0904-7493, 70771-1673 +8Application ANDA212490, ANDA208256, ANDA208303 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 68382-624-31 | Zydus LifesciencesIndia | 18 May 2023 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-624-83 | Zydus LifesciencesIndia | 18 May 2023 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1673-3 | Zydus LifesciencesIndia | 18 May 2023 |
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 70771-1673-8 | Zydus LifesciencesIndia | 18 May 2023 |
| 500 tablet in 1 bottle | 67877-730-05 | Ascend LaboratoriesIndia | 14 March 2025 |
| 30 tablet in 1 bottle | 67877-730-30 | Ascend LaboratoriesIndia | 14 March 2025 |
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 67877-730-87 | Ascend LaboratoriesIndia | 14 March 2025 |
| 90 tablet in 1 bottle | 67877-730-90 | Ascend LaboratoriesIndia | 14 March 2025 |
| 4 blister pack in 1 carton / 7 tablet in 1 blister pack | 67877-730-93 | Ascend LaboratoriesIndia | 14 March 2025 |
| 1 blister pack in 1 carton / 20 tablet in 1 blister pack | 59651-801-20 | Aurobindo PharmaIndia | 31 January 2025 |
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 59651-801-28 | Aurobindo PharmaIndia | 31 January 2025 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-676-32 | Camber PharmaceuticalsIndia | 18 April 2023 |
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 31722-676-36 | Camber PharmaceuticalsIndia | 18 April 2023 |
| 28 tablet in 1 blister pack | 59746-801-70 | Jubilant Cadista PharmaceuticalsIndia | 2 February 2026 |
| 500 tablet in 1 bottle | 42571-369-05 | Micro LabsIndia | 1 May 2023 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 42571-369-11 | Micro LabsIndia | 1 May 2023 |
| 30 tablet in 1 bottle | 42571-369-30 | Micro LabsIndia | 1 May 2023 |
| 28 tablet in 1 bottle | 42571-369-83 | Micro LabsIndia | 1 May 2023 |
| 90 tablet in 1 bottle | 42571-369-90 | Micro LabsIndia | 1 May 2023 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 72205-201-24 | Novadoz PharmaceuticalsIndia | 24 September 2022 |
| 30 tablet in 1 bottle | 72205-201-30 | Novadoz PharmaceuticalsIndia | 21 December 2022 |
| 2 blister pack in 1 carton / 14 tablet in 1 blister pack | 72205-201-32 | Novadoz PharmaceuticalsIndia | 24 September 2022 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 69292-630-10 | Amici Pharma | 5 February 2026 |
| 1 blister pack in 1 carton / 14 tablet in 1 blister pack | 69292-630-14 | Amici Pharma | 5 February 2026 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 69292-630-20 | Amici Pharma | 5 February 2026 |
| 2 blister pack in 1 carton / 14 tablet in 1 blister pack | 69292-630-28 | Amici Pharma | 5 February 2026 |
| 2 blister pack in 1 box / 14 tablet in 1 blister pack | 73190-086-28 | AvKARE | 24 June 2026 |
| 28 tablet in 1 bottle | 0904-7493-71 | Major Pharmaceuticals | 27 October 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Roflumilast 250 mcg tablet.
Other strengths and forms of Roflumilast
Clinical summary
Roflumilast is a phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, among other approved uses. MedsAcross supplies Roflumilast for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about RoflumilastFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Daliresp prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Daxas: European public assessment report (EPAR) · European Medicines Agency
Need Roflumilast 250 mcg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.